FDA
New Life told FDA inspectors that they lacked the authority to enter parts of a facility where it made the GLP-1 receptor agonists semaglutide and tirzepatide.
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BioSpace looks back at 2025 and where the FDA is going in 2026.
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
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Shares of Voyager Therapeutics fell in aftermarket trading after its CEO and CMO announced plans to depart the company following clinical setbacks with a Parkinson’s disease program.
Several biopharmaceutical companies have submitted NDAs to the U.S. FDA covering treatment indications ranging from an opioid overdose, bipolar disorder and rare disease.
X-Vax Technology is ready to submit an IND application to the U.S. FDA for its experimental herpes vaccine against HSV-1 and -2. Here’s what you need to know.
The FDA further delays Iovance’s filing for its TIL therapy as it requests additional data on the treatment’s potency assays.
FDA says it is possible booster shots would be necessary for fully vaccinated individuals within a year even though vaccines are highly effective at COVID-19 prevention.
BMS inked a collaboration agreement with Exscientia that can leverage AI to speed the discovery of drug candidates in therapeutic areas, including oncology and immunology.
The U.S. FDA scolded CytoDyn for misrepresenting its clinical trial results for Leronlimab in COVID-19. Here’s what FDA has to say regarding CytoDyn Leronlimab.
The high court’s decision will prevent Sandoz from launching its biosimilar to Amgen’s blockbuster rheumatoid arthritis drug.
A recent Phase II trial show Regeneron’s monoclonal antibody evinacumab significantly reduced fasting triglycerides in patients with severe hypertriglyceridemia.
Empaveli (pegcetacoplan) is the first and only targeted C3 therapy for the treatment of adults with PNH, the Waltham, Mass.-based company said in its announcement.